Details for New Drug Application (NDA): 210797
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NDA 210797 describes SCENESSE, which is a drug marketed by Clivunel Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SCENESSE profile page.
The generic ingredient in SCENESSE is afamelanotide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the afamelanotide profile page.
The generic ingredient in SCENESSE is afamelanotide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the afamelanotide profile page.
Summary for 210797
| Tradename: | SCENESSE |
| Applicant: | Clivunel Inc |
| Ingredient: | afamelanotide |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210797
Generic Entry Date for 210797*:
Constraining patent/regulatory exclusivity:
INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) Dosage:
IMPLANT;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 210797
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797 | NDA | CLINUVEL INC. | 73372-0116 | 73372-0116-1 | 1 VIAL, GLASS in 1 CARTON (73372-0116-1) / 1 mg in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;SUBCUTANEOUS | Strength | 16MG | ||||
| Approval Date: | Oct 8, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 8, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) | ||||||||
| Regulatory Exclusivity Expiration: | Oct 8, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 11, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) | ||||||||
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